Resistance Exercise, IL-7 and Immune Phenotypes in Prostate Cancer
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexMale
Age18+
SponsorUniversity of Bath
About this trial
Hormone therapy for prostate cancer typically causes significant muscle loss. Skeletal muscle releases Interleukin-7 (IL-7), a signalling protein that supports the production of new immune cells. Therefore, losing muscle during cancer treatment may actively weaken the immune system. The goal of this clinical trial is to investigate if a 12-week supervised resistance exercise (strength training) programme can prevent this muscle loss and increase levels of IL-7.
The main questions it aims to answer are:
* Does a 12-week strength training programme raise resting IL-7 levels and increase newly formed immune cell counts? * Does a single session of strength training trigger an immediate release of IL-7? * To what extent do exercise-induced improvements in muscle mass and strength translate into reduced fatigue, better physical function, higher quality of life, and improved cardiometabolic health? * Is the exercise programme safe and well-tolerated during hormone therapy?
Researchers will compare a Resistance Exercise Group to a Usual Care Group to see the effects of strength training against standard medical care.
Participants will:
* Attend a screening visit to check eligibility. * Complete baseline assessments, including body composition scans, blood tests, fitness tests, and questionnaires. * Be randomly assigned to either the exercise group or the usual care group. * Complete three supervised strength training sessions per week for 12 weeks, if assigned to the exercise group. * Continue with standard medical care, if assigned to the usual care group. * Repeat all assessments at the end of the 12 weeks. * Perform one short exercise session during the final visit, with extra blood samples taken before and after to track immediate changes
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Histologically confirmed diagnosis of localised prostate cancer (clinical stage T1-3b, N0-1, M0 and a Gleason score of 6-10).
Scheduled to undergo curative-intent treatment involving neoadjuvant androgen deprivation therapy (ADT) for a duration of at least 3 months, alongside radiotherapy.
Recruited prior to, or within the first 2 weeks of, initiating ADT.
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
Disqualifiers
Evidence of distant metastases (M1).
Uncontrolled cardiovascular conditions (e.g., uncontrolled hypertension, unstable angina, or a myocardial infarction within the past 6 months).
Musculoskeletal pathologies or conditions that would preclude the safe execution of resistance exercise.
A known history of autoimmune disease.
Trial design
Design model
Parallel
Treatments tested in this trial
Supervised Resistance Exercise Programme
Other interventionA 12-week, supervised resistance training programme delivered in small groups in a gym setting. Participants will train 3 times per week on non-consecutive days, with sessions lasting 45-60 minutes. The programme targets all major muscle groups, with volume and intensity gradually increasing throughout the intervention period.
Treatment groups
40 Participants
are divided into 2 treatment groupsGroup A: Usual Care GroupNo intervention 0 interventions
Group B: Resistance Exercise GroupExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Change in Resting Interleukin-7 (IL-7) Concentration
Assessed via enzyme-linked immunosorbent assay (ELISA) from resting, fasting blood samples to evaluate changes in baseline immune-supporting signaling proteins.
Time frame
Baseline and 12 weeksSecondary outcomes
1
Change in Frequencies of Resting Immune Cell Phenotypes
Assessed via flow cytometry from resting, fasting blood samples to evaluate key immune cell populations, specifically naïve CD4+ T-cells, naïve CD8+ T-cells, and naïve B-cells.
Time frame
Baseline and 12 weeks2
Acute Circulating IL-7 Response to a Single Bout of Exercise
Quantified as the incremental Area Under the Curve (iAUC) of circulating IL-7 via ELISA. Blood samples are taken at rest, immediately post-exercise, and 30 minutes post-exercise.
Time frame
Week 123
Change in Total Lean Mass
Measured via Dual-Energy X-ray Absorptiometry (DEXA) to evaluate changes in lean tissue.
Time frame
Baseline and 12 weeks4
Change in Total Fat Mass
Measured via Dual-Energy X-ray Absorptiometry (DEXA) to evaluate changes in body fat.
Time frame
Baseline and 12 weeksSponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Bath
Lead sponsor
Royal United Hospitals Bath NHS Foundation Trust
Collaborator
Source ClinicalTrials.gov
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